Introduction: Regulation of Allergen Products and the German - - PowerPoint PPT Presentation

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Introduction: Regulation of Allergen Products and the German Regulation for Therapy Allergens

Stefan Vieths

Paul-Ehrlich-Institut, Division of Allergology

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Regulatory Background

• Allergens subjected to European pharmaceutical

legislation in 1989 (Directive 89/342/EEC)

• Definition of directive 2001/83/EC:

“medicinal product which is intended to identify

• r induce a specific acquired alteration in the

immunological response to an allergizing agent”

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Regulatory Background

• 1. This Directive shall apply to medicinal products for

human use intended to be placed on the market in Member States and either prepared industrially

• r manufactured by a method involving

an industrial process. Article 2 of Directive 2001/83/EC (Scope)

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Directive 2001/83/EC

• 1. No medicinal product may be placed on the market
• f a Member State unless a marketing authorization

has been issued by the competent authorities of that Member State in accordance with this Directive

• r an authorization has been granted in accordance

with Regulation (EEC) No 2309/93. Marketing authorization (Article 6)

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German Medicinal Products Act (Arzneimittelgesetz, last amendment July 2009)

• Scope of Directive 2001/83 fully implemented but:
• § 21:

(2) A marketing authorization shall not be required for medicinal products which … 1g. are manufactured for individual persons on prescription as therapy allergens…

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Named Patient Products - Background

• Allergen extracts manufactured from allergenic

source material originating from the environment

• f an individual patient.
• Allergen extracts prepared from commercial

source material or intermediate products (bulks) on the basis of a prescription for an individual patient.

• Allergen extract mixtures prepared from industrially

manufactured intermediate products (bulks) on the basis of a prescription for an individual patient. Types of Named Patient Products

May S, Haustein D, Bundesgesundheitsbl. 2001, 44:719-723

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Rationale of Named Patient Products

 Offer SIT as therapeutic option to those patients, whose allergies can not be treated with authorized products because

• the patients suffer from “rare” allergies;
• the patients are poly-sensitized to a certain

combination of allergens.

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Regulatory requirements for NPPs

 Manufacturing license (§13 Sect. 1 AMG) (authorities of federal states in consultation with PEI).  Production according to good manufacturing practice audited.

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NPPs – differences to authorized products

 No independent evaluation of quality, efficacy, and safety required.  No demand for manufacturer to notify adverse events.  No independent risk-benefit analysis possible.

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Bypassing marketing authorization?

 According to product lists of manufacturers 26 single allergen extracts from birch pollen are marketed in Germany.  Marketing authorizations have been granted for six.  Prevalence of birch pollen allergy is estimated at 10%.

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Initiative of German Federal Ministry of Health

„Verordnung über die Ausdehnung der Vorschriften über die Zulassung der Arzneimittel auf Therapieallergene, die für einzelne Personen auf Grund einer Rezeptur hergestellt werden, sowie über Verfahrensregelungen der staatlichen Chargenprüfung“ (Therapieallergene-Verordnung) Regulation for Therapy Allergens

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Regulation for Therapy Allergens – Content

 NPPs produced from industrially manufactured bulks are subjected to marketing authorization.  Industrially manufactured bulks used for preparation of NPPs are subjected to batch release by the Paul-Ehrlich-Institut.  List of allergens concerned given in Appendix

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List of Allergens – Content

Appendix  Grass species of the Poaceae family except Poa mays  Betula sp. (birch)  Alnus sp. (alder)  Corylus sp. (hazel)  Dermatophagoides sp. (dust mites)  Bee venom  Wasp venom

Mixtures containing one or more allergens from the list are subjected to marketing authorization.

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Transition Periods according to the New Regulation and Relevant Dates

 Notification of product to PEI within 6 months. Done on the 14th of May 2009  Application for marketing authorization by December 1st, 2010  Prolongation of transition period of up to 7 years possible, if justified. .

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Paediatric Investigation Plans (PIPs)

• Authorization of new medicines requires a PIP

approved by PDCO (Regulation (EC) No 1901/2006).

• Without approved PIP no marketing authorization

for adults will be granted.

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• 178 applications for marketing authorization have

been announced

• Approved PIPs have to be submitted with the

application (December 1st 2010)

• Concept of „Homologous Groups“ may reduce the

number of necessary PIPs to approx. 80

• To reduce the expenditure of work during the

evaluation phase an EMEA/PDCO Draft Standard PIP for Allergen Products for SIT was developed.

PIPs related to German Regulation for Therapy Allergens

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CHMP CVMP COMP HMPC PDCO

Committee for Medicinal Products for Human Use Committee for Medicinal Products for Veterinary Use Committee for Orphan Medicinal Products Committee on Herbal Medicinal Products Paediatric Committee

CAT

Committee for Advanced Therapies

The EMEA‘s committees